Status:
RECRUITING
A Study of Intravenous M1-c6v1 for Locally Advanced or Metastatic Solid Tumors
Lead Sponsor:
Guangzhou Virotech Pharmaceutical Co., Ltd.
Conditions:
Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
A Phase I Study of the Safety and Tolerability of M1-c6v1 Administered Via Intravenously for Treatment of Patients With Locally Advanced or Metastatic Solid Tumors
Detailed Description
This study is an open-label, dose-escalation clinical study which aims to evaluate the safety and tolerability of multiple IV injections of M1-c6v1 in subjects with locally advanced/metastatic solid t...
Eligibility Criteria
Inclusion
- Subjects must have diagnosis of locally advanced or metastatic solid tumors who are intolerable or refractory to the standard therapy.
- Subject voluntarily agrees to participate in this study and signs an Institutional Review Board -approved informed consent prior to performing any of the Screening Visit procedures.
- Males and females at least 18 years of age, inclusive, at the Screening Visit.
- Have at least one measurable lesion.
- An Eastern Cooperative Oncology Group (ECOG) score of 0-1, 1 week before the first administration of IMP.
- An estimated survival time of ≥ 12 weeks.
Exclusion
- Subject has a history of primary or acquired immunodeficient states, leukemia, lymphoma, acquired immunodeficiency syndrome (AIDS) or other clinical manifestations of infection with human immunodeficiency viruses, and those on immunosuppressive therapy.
- Subject has received any anti-tumor treatment 4 weeks before using the IMP, including chemotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy.
- Subject has received systemic glucocorticoids (prednisone \>10 mg/day or equivalent doses of similar drugs) or other immunosuppressive agents within 14 days prior to first administration of IMP.
- Subject has received immunomodulatory drugs, including but not limited to thymosin, IL-2, IFN, etc. within 14 days prior to first administration of IMP.
Key Trial Info
Start Date :
July 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 20 2026
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06046742
Start Date
July 10 2024
End Date
December 20 2026
Last Update
March 13 2025
Active Locations (3)
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1
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan
2
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, Japan
3
St. Marianna University Hospital
Kawasaki-shi, Kanagawa, Japan